July 2nd Week, 2025 Regulatory Updates 🎯 The EC approved BeOne Medicines' tislelizumab (anti-PD-1) + gemcitabine + cisplatin for the first-line Tx of metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy. (Ref 1) ❓ What are the other key Asia-specific trials emerging in this indication? 🎯 The UK’s MHRA granted marketing authorization to ImmunityBio, Inc.'s nogapendekin alfa inbakicept-pmln (lymphocyte-stimulating agent

10/07/2025 TEVIMBRA + chemotherapy has been approved in EU as a first-line treatment for NPC (Ref) The EC approved BeOne Medicines' tislelizumab (TEVIMBRA; anti-PD-1) + gemcitabine + cisplatin for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy The approval is based on results from the Phase 3 RATIONALE-309 trial which met the primary endpoint of PFS (HR 0.52; p<0.0001)

March 3rd Week, 2025 Regulatory Events 🎯 The US FDA granted traditional approval to Merck & Co./MSD’s pembrolizumab (anti-PD-1) + trastuzumab (anti-HER2) + fluoropyrimidine- and platinum-containing chemo for the first-line treatment of adults with locally advanced, unresectable/metastatic HER2+ve gastric/gastroesophageal junction adenocarcinoma with PD-L1 CPS ≥1 (Ref 1). The regimen was previously granted accelerated approval for this indication in May’21. ❓ Which other re

March 1st Week, 2025 Regulatory Events 🎯 Bristol Myers Squibb’ nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) has been approved by the EC as a first-line Tx for unresectable or advanced HCC. (Ref 1) ❓ How do the outcomes of nivolumab + ipilimumab compare against the previously approved Tx options for the first-line HCC? 🎯 Johnson & Johnson's amivantamab (EGFR x MET BsAb) + lazertinib (EGFR TKI) has been approved by the UK's MHRA for EGFR mutant, metastatic NSCLC. (Ref 2)